I’m delighted to begin sharing the insights that emerge from the deeply satisfying work of helping biopharma leaders innovate. Every day, I have the privilege of reflecting on problems at the edge of innovation with committed scientists and leaders. Every time we succeed with a new approach, I think of a dozen people who could […]
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Do you watch different functions blame each other for problems? You’re not alone. Problem: A recent client was bringing its first compound to Phase Two after decades of research on a new class of therapeutic agents. An investor deadline loomed for starting the dose-finding study. Development was pushing to finalize the study but Research continued […]
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Can’t get people out of their silos? You’re not alone. Problem: An early-stage company needed to demonstrate Proof of Concept for a novel therapy, but the organization could not reach agreement on a clinical protocol design. My client Peter, the Program Executive, vented his frustration to me: “Dr. C [the Clinical Director] withdraws, withholds information, […]
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Find it hard to innovate in the strictly regulated environment of drug development? You’re not alone. Problem: Recently, a client company faced a competitive threat to their leading product. The FDA issued new manufacturing guidelines that would have taken three years to implement, while their competition had already complied. The PD (process development) team proposed […]
Follow my New Blog, Merle Kummer Insights
in Innovation CultureI’m delighted to begin sharing the insights that emerge from the deeply satisfying work of helping biopharma leaders innovate. Every day, I have the privilege of reflecting on problems at the edge of innovation with committed scientists and leaders. Every time we succeed with a new approach, I think of a dozen people who could […]
Using Powerful Questions to Align Research and Development
in Cross-Functional Leadership, Difficult Conversations, Managing Conflict, Protocol DevelopmentDo you watch different functions blame each other for problems? You’re not alone. Problem: A recent client was bringing its first compound to Phase Two after decades of research on a new class of therapeutic agents. An investor deadline loomed for starting the dose-finding study. Development was pushing to finalize the study but Research continued […]
Finding the Best Path to a Clinical Protocol Design
in Innovation Culture, Organizational Politics, Protocol DevelopmentCan’t get people out of their silos? You’re not alone. Problem: An early-stage company needed to demonstrate Proof of Concept for a novel therapy, but the organization could not reach agreement on a clinical protocol design. My client Peter, the Program Executive, vented his frustration to me: “Dr. C [the Clinical Director] withdraws, withholds information, […]
Innovating In Highly Regulated Settings
in Decision-Making, Experiment Design, Innovation CultureFind it hard to innovate in the strictly regulated environment of drug development? You’re not alone. Problem: Recently, a client company faced a competitive threat to their leading product. The FDA issued new manufacturing guidelines that would have taken three years to implement, while their competition had already complied. The PD (process development) team proposed […]